At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 336 enrolled
Drug / intervention
Brexpiprazole +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial of Brexpiprazole (1 - 3 mg/Day) as Monotherapy or as Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jan 26, 2017·Updated Dec 8, 2021
In Brief
A Phase 2 clinical trial evaluating Brexpiprazole, Sertraline, and 2 other interventions for Stress Disorders, Post-Traumatic. Completed, enrolled 336 participants across 54 sites.
Detailed Summary
To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStress Disorders, Post-Traumatic
CountriesUnited States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartJan 2017
Primary CompletionNov 2018
TodayJul 2026
First PostedJan 26, 2017
Enrollment StartJan 26, 2017
Primary CompletionNov 12, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.4 years ago
Interventions
Brexpiprazoledrug
Brexpiprazole oral tablets.
Sertralinedrug
Sertraline oral capsules.
Brexpiprazole Matching Placebodrug
Brexpiprazole matching placebo oral tablets.
Sertraline Matching Placebodrug
Sertraline matching placebo oral capsules.